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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bronchoscope accessory
Definition If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Product CodeKTI
Regulation Number 874.4680
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCLARENT, INC.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BRYAN MEDICAL , INC.
  SUBSTANTIALLY EQUIVALENT 1
DISA MEDINOTEC
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN TT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GA HEALTH COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
INTUIT MEDICAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
M/S MERIL LIFE SCIENCES PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDIVATORS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MICRO-TECH (NANJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS SURGICAL TECHNOLOGIES AMERICA
  SUBSTANTIALLY EQUIVALENT 4
PRAXIS MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
SERPEX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPIRATION, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 4 4
2015 2 2
2016 7 7
2017 9 9
2018 14 14
2019 27 27
2020 37 37
2021 47 47
2022 131 131
2023 130 130
2024 24 24

Device Problems MDRs with this Device Problem Events in those MDRs
Break 73 73
Mechanical Problem 55 55
Detachment of Device or Device Component 47 47
Burst Container or Vessel 34 34
Retraction Problem 28 28
Material Puncture/Hole 26 26
Leak/Splash 25 25
Material Separation 25 25
Adverse Event Without Identified Device or Use Problem 22 22
Material Twisted/Bent 20 20
Physical Resistance/Sticking 19 19
Use of Device Problem 17 17
Device Fell 12 12
Defective Device 10 10
Difficult to Advance 7 7
Unintended Movement 7 7
Difficult to Remove 7 7
Material Split, Cut or Torn 7 7
Deflation Problem 5 5
Mechanical Jam 5 5
Separation Failure 5 5
Device Slipped 5 5
Output Problem 5 5
Separation Problem 4 4
Material Fragmentation 4 4
Failure to Obtain Sample 4 4
Material Deformation 4 4
Component Missing 4 4
Device Dislodged or Dislocated 3 3
Deformation Due to Compressive Stress 3 3
Inflation Problem 3 3
Defective Component 3 3
Failure to Advance 3 3
Insufficient Information 3 3
Material Perforation 2 2
Entrapment of Device 2 2
Unstable 2 2
Improper or Incorrect Procedure or Method 2 2
Fail-Safe Did Not Operate 1 1
Compatibility Problem 1 1
Material Integrity Problem 1 1
Bent 1 1
Device Reprocessing Problem 1 1
Fracture 1 1
Failure To Unwrap 1 1
Activation, Positioning or Separation Problem 1 1
Disassembly 1 1
Suction Problem 1 1
Difficult to Open or Close 1 1
Failure to Eject 1 1
Difficult or Delayed Positioning 1 1
Activation Failure 1 1
Failure to Disconnect 1 1
Difficult to Insert 1 1
Loose or Intermittent Connection 1 1
Device Markings/Labelling Problem 1 1
Scratched Material 1 1
Positioning Problem 1 1
Firing Problem 1 1
Disconnection 1 1
Torn Material 1 1
Inadequate User Interface 1 1
Microbial Contamination of Device 1 1
Fluid/Blood Leak 1 1
Failure to Discharge 1 1
Cut In Material 1 1
Display or Visual Feedback Problem 1 1
Collapse 1 1
Detachment Of Device Component 1 1
Fitting Problem 1 1
Hole In Material 1 1
Device Handling Problem 1 1
Material Too Rigid or Stiff 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 285 285
No Consequences Or Impact To Patient 55 55
Foreign Body In Patient 27 27
No Known Impact Or Consequence To Patient 27 27
Insufficient Information 10 10
Hemorrhage/Bleeding 6 6
No Code Available 5 5
Hypoxia 3 3
Unspecified Infection 2 2
Device Embedded In Tissue or Plaque 2 2
Pneumothorax 2 2
Abscess 2 2
Chest Pain 2 2
Embolism 1 1
Fever 1 1
Hemoptysis 1 1
Airway Obstruction 1 1
Bacterial Infection 1 1
Cardiac Arrest 1 1
Foreign body, removal of 1 1
Breathing difficulties 1 1
Tooth Fracture 1 1
Needle Stick/Puncture 1 1
Low Oxygen Saturation 1 1
Respiratory Failure 1 1
Decreased Respiratory Rate 1 1
Sleep Dysfunction 1 1
No Patient Involvement 1 1
Scar Tissue 1 1
Perforation of Vessels 1 1
Cough 1 1
Unspecified Respiratory Problem 1 1
Unspecified Tissue Injury 1 1
No Information 1 1
Pneumonia 1 1
Low Blood Pressure/ Hypotension 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Acclarent, Inc. II Aug-01-2013
2 Acclarent, Inc. I Mar-01-2012
3 Bryan Medical Inc II Jul-17-2023
4 Richard Wolf GmbH II Feb-06-2019
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